This page separates reported trial results from statistical interpretation. Numerical results and trial-specific design facts are limited to the ClinicalTrials.gov data posted on ClinicalTrials.gov for NCT02952586. Where the registry does not provide a requested detail, it is not inferred from other sources.
1. Trial at a Glance
JAVELIN Head and Neck 100 was a randomized, parallel-group, quadruple-masked phase 3 trial evaluating avelumab in combination with standard of care chemoradiotherapy versus placebo with standard of care chemoradiotherapy for definitive treatment of squamous cell carcinoma of the head and neck. The registry reports 697 participants enrolled and a primary endpoint based on progression-free survival.
| Feature | JAVELIN Head and Neck 100 |
|---|---|
| Phase | Phase 3 |
| Condition | Squamous Cell Carcinoma of the Head and Neck |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Primary purpose | Treatment |
| Enrollment | 697 |
| Interventions | Avelumab and chemoradiation |
| Results posted | Yes |
| Outcome measures posted | 25 |
| Statistical analyses posted | 5 |
| Trial status | Terminated |
2. Clinical Question
The central statistical question was whether adding avelumab to standard of care chemoradiotherapy changed progression-free survival compared with standard of care chemoradiotherapy alone in patients with squamous cell carcinoma of the head and neck.
Population
Patients with squamous cell carcinoma of the head and neck enrolled in the phase 3 randomized trial.
Intervention
Avelumab plus standard of care chemoradiotherapy.
Comparator
Placebo plus standard of care chemoradiotherapy.
Primary question
Does avelumab plus standard of care chemoradiotherapy improve investigator-assessed progression-free survival compared with placebo plus standard of care chemoradiotherapy?
3. Trial Design
Avelumab + Standard of Care Chemotherapy
- Avelumab
- Standard of care chemoradiotherapy
- Time-to-event efficacy outcomes assessed in the full analysis set
Placebo + SOC CRT
- Placebo
- Standard of care chemoradiotherapy
- Time-to-event efficacy outcomes assessed in the full analysis set
The ClinicalTrials.gov record describes the study as randomized, parallel, and quadruple-masked. These design features are important statistically because randomization creates the basis for comparing outcomes between treatment assignments, while masking can reduce the influence of treatment knowledge on trial conduct and assessment.
Trial timeline
Study start
The registry lists November 28, 2016 as the trial start date.
Primary completion
The registry lists December 23, 2019 as the primary completion date.
Terminated
The ClinicalTrials.gov record identifies the study status as terminated.
4. Endpoints
The registry identifies one registered primary endpoint and reports five formal statistical analyses in total: one primary analysis and four secondary analyses.
| Endpoint | Registry definition / time frame | Analysis |
|---|---|---|
| Primary: Progression-free Survival (PFS) | Progression-free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as Assessed by Investigator. From randomization until documented PD or death, censored date, whichever occurred first (up to 37 months). | Kaplan-Meier method; log-rank comparison; hazard ratio |
| Secondary: Overall Survival (OS) | From randomization to the date of death or censored date, whichever occurred first (up to 37 months). | Log-rank comparison; hazard ratio |
| Secondary: Time to Locoregional Failure | Time to Locoregional Failure Per Modified RECIST v1.1 as Assessed by Investigator. From the date of randomization to the date of the first documentation of locoregional recurrence or death, whichever occurred first. | Log-rank comparison; hazard ratio |
| Secondary: Objective Response Rate (ORR) | Objective Response Rate (ORR) Per Modified RECIST v1.1 as Assessed by Investigator. From randomization until disease progression or death, whichever occurred first (up to 37 months). | Cochran-Mantel-Haenszel test; odds ratio |
| Secondary: Time to Distant Metastatic Failure | Time to Distant Metastatic Failure Per Modified RECIST v1.1 as Assessed by Investigator. From the date of randomization to the date of the first documentation of distant metastatic or death (up to 37 months). | Log-rank comparison; hazard ratio |
5. Statistical Methodology
Full analysis set
The registry defines the analysis population for all five reported statistical analyses as the full analysis set (FAS), which included all randomized participants. This is important because the efficacy comparison remains anchored to treatment assignment rather than being restricted to participants who completed treatment or were fully evaluable after randomization.
Kaplan-Meier estimation
The primary PFS definition states that analysis was performed using the Kaplan-Meier method. Kaplan-Meier estimation is designed for time-to-event data in which some participants may not have experienced the event by the end of their observed follow-up. Such observations are censored rather than treated as though the event occurred at the censoring time.
Here, di represents the number of events at an event time and ni represents the number at risk immediately before that time.
Log-rank testing
The primary PFS analysis and three of the four secondary analyses used the log-rank test. This is a standard approach for comparing time-to-event distributions between randomized groups across follow-up rather than comparing a single time point.
Hazard ratios
The primary PFS, OS, time to locoregional failure, and time to distant metastatic failure analyses all reported hazard ratios. A hazard ratio summarizes the relative event rate between groups within the time-to-event analysis framework.
An HR of 1 corresponds to equal estimated hazards. An HR above 1 indicates a higher estimated hazard in the numerator group, while an HR below 1 indicates a lower estimated hazard, subject to the model and analysis assumptions.
Cochran-Mantel-Haenszel testing
The objective response rate analysis used a Cochran-Mantel-Haenszel test and reported an odds ratio. Unlike PFS and OS, ORR is a binary endpoint: participants are classified according to whether they met the response definition during the specified assessment period.
6. Results: Primary Endpoint
The registry reports a formal statistical analysis for the primary endpoint, investigator-assessed PFS. The comparison used the full analysis set and a log-rank test, with the treatment effect summarized by a hazard ratio.
Progression-Free Survival
Hazard ratio for progression or death
95% CI: 0.928–1.573 · P = 0.9199
Two-sided confidence interval · Superiority hypothesis
| Primary endpoint | Avelumab + SOC CRT | Placebo + SOC CRT | Effect estimate |
|---|---|---|---|
| Investigator-assessed PFS | Full analysis set | Full analysis set | HR 1.21 (95% CI 0.928–1.573); P = 0.9199 |
The registry describes the endpoint as time from randomization until documented progressive disease or death, with the analysis extending to a censored date when neither event had occurred and with the registry time frame extending up to 37 months.
An HR of 1.21 means that the estimated hazard for the avelumab-plus-SOC-CRT group relative to the placebo-plus-SOC-CRT group was 1.21 within the reported time-to-event analysis. Expressed descriptively, the point estimate is above 1 rather than below 1.
This does not mean that 21% more patients progressed or died, nor does it mean that an individual patient's probability of progression or death increased by 21%. A hazard ratio is a relative time-to-event measure, not an absolute risk difference.
The two-sided 95% confidence interval of 0.928 to 1.573 describes the uncertainty around the estimated hazard ratio under the analysis framework. Because the interval spans 1, the estimate is compatible with hazard ratios below 1 as well as above 1.
The reported P = 0.9199 is a measure used for the statistical comparison under the prespecified superiority framework. It is not a measure of effect size, clinical importance, or the probability that the treatment is effective or ineffective.
As with other hazard-ratio analyses, interpretation also depends on the time-to-event framework, censoring, and the extent to which a single relative hazard summarizes the treatment comparison over follow-up. The ClinicalTrials.gov record does not report a proportional-hazards diagnostic or a separate assessment of that assumption.
7. Secondary Endpoint Results
The registry reports four secondary statistical analyses. Three are time-to-event endpoints analyzed with the log-rank test and summarized by hazard ratios. ORR is a binary endpoint analyzed with the Cochran-Mantel-Haenszel test and summarized by an odds ratio.
Overall Survival
Hazard ratio for death
95% CI: 0.927–1.849 · P = 0.9372
Two-sided confidence interval · Superiority hypothesis
The OS hazard ratio of 1.31 is the estimated relative hazard for death comparing avelumab plus SOC CRT with placebo plus SOC CRT in the full analysis set. The point estimate is above 1.
The 95% CI of 0.927–1.849 includes 1, so the reported interval is compatible with both a lower and a higher hazard under the treatment-group comparison. The confidence interval therefore communicates substantial uncertainty around the point estimate.
The reported P = 0.9372 is evidence from the specified statistical comparison, not a measure of how large the treatment effect is. It should be interpreted alongside the hazard ratio and confidence interval rather than substituted for them.
Time to Locoregional Failure
Hazard ratio
95% CI: 0.930–1.694 · P = 0.9316
Two-sided confidence interval · Superiority hypothesis
The hazard ratio of 1.25 is the estimated relative hazard for the time-to-locoregional-failure endpoint in the avelumab-plus-SOC-CRT group compared with the placebo-plus-SOC-CRT group.
The 95% CI of 0.930–1.694 crosses 1. The interval therefore does not identify a single direction of the underlying hazard ratio with the precision implied by an interval entirely on one side of 1.
The reported P = 0.9316 should not be interpreted as a percentage measure of treatment effect. The endpoint is also subject to the usual time-to-event considerations of censoring and the interpretation of a relative hazard over follow-up.
Objective Response Rate
Odds ratio for objective response
95% CI: 0.663–1.352 · P = 0.6229
Two-sided confidence interval · Superiority hypothesis
An OR of 0.947 compares the odds of objective response between the two randomized groups under the Cochran-Mantel-Haenszel analysis. An odds ratio of 1 would indicate equal odds under the comparison's defined direction.
The 95% CI of 0.663–1.352 includes 1, indicating uncertainty that spans both sides of the null value. The odds ratio should not be read as a probability ratio; odds and probabilities are different quantities.
The reported P = 0.6229 describes the statistical comparison and does not itself quantify the magnitude or clinical importance of the observed odds ratio.
Time to Distant Metastatic Failure
Hazard ratio
95% CI: 0.909–1.624 · P = 0.9061
Two-sided confidence interval · Superiority hypothesis
The reported HR of 1.21 is the estimated relative hazard for time to distant metastatic failure in the avelumab-plus-SOC-CRT group compared with the placebo-plus-SOC-CRT group.
The 95% CI of 0.909–1.624 includes 1, so the interval encompasses both directions of the relative hazard comparison. The width of the interval also illustrates why the point estimate should not be treated as a precise description of the underlying treatment effect.
The reported P = 0.9061 is a test statistic result, not a measure of effect magnitude. Interpretation should consider the hazard ratio, its confidence interval, the endpoint definition, censoring, and the randomized analysis population together.
8. Results Summary
| Endpoint | Method | Effect measure | Estimate | 95% CI | P-value |
|---|---|---|---|---|---|
| Primary: PFS | Log-rank | Hazard ratio | 1.21 | 0.928–1.573 | 0.9199 |
| OS | Log-rank | Hazard ratio | 1.31 | 0.927–1.849 | 0.9372 |
| Time to locoregional failure | Log-rank | Hazard ratio | 1.25 | 0.930–1.694 | 0.9316 |
| ORR | Cochran-Mantel-Haenszel | Odds ratio | 0.947 | 0.663–1.352 | 0.6229 |
| Time to distant metastatic failure | Log-rank | Hazard ratio | 1.21 | 0.909–1.624 | 0.9061 |
Across the five posted statistical analyses, the ClinicalTrials.gov record shows hazard-ratio point estimates above 1 for all four time-to-event comparisons and an odds-ratio point estimate of 0.947 for objective response. All five reported two-sided confidence intervals include the corresponding null value of 1.
9. Safety: Serious Adverse Events
The ClinicalTrials.gov record reports serious adverse events by randomized arm using affected participants over participants at risk. No additional safety endpoints are provided in the ClinicalTrials.gov record, so the safety summary is limited to this measure.
| Safety measure | Avelumab + Standard of Care Chemotherapy | Placebo + SOC CRT |
|---|---|---|
| Serious adverse events, affected / at risk | 184 / 348 | 177 / 344 |
The denominators are not the same as the total enrollment of 697 because the reported safety measure is expressed using its own affected and at-risk counts. The ClinicalTrials.gov record does not provide a formal statistical comparison for serious adverse events, so no additional inferential conclusion is added.
10. Statistical Methods Explained
Why was a log-rank test used for PFS?
PFS is a time-to-event endpoint. Participants can experience progression or death at different times, while others may remain event-free when their observed follow-up ends. The log-rank test is designed to compare the survival distributions of two groups while incorporating the timing of events and censoring rather than reducing the endpoint to a single binary outcome.
What does the PFS hazard ratio of 1.21 mean?
The HR of 1.21 is the reported relative hazard estimate for PFS comparing avelumab plus SOC CRT with placebo plus SOC CRT. It is not a 21% difference in the proportion of participants who progressed, and it is not an individual-level probability. It summarizes the relative event rate within the time-to-event analysis framework.
Why is the confidence interval important?
A point estimate is only one estimate from the data. The reported 95% CI describes statistical uncertainty around that estimate. For PFS, the interval is 0.928–1.573, which spans 1. This means the plausible range represented by the interval includes both a hazard ratio below 1 and one above 1 under the stated inferential framework.
Why doesn't the P-value measure effect size?
A P-value addresses the statistical evidence against a specified null hypothesis under the analysis model. It does not tell us how large the treatment effect is. The effect size is conveyed by the hazard ratio or odds ratio, while the confidence interval provides information about uncertainty around that effect estimate.
Why was the Cochran-Mantel-Haenszel test used for ORR?
ORR is a binary endpoint rather than a time-to-event endpoint. A Cochran-Mantel-Haenszel approach provides a way to compare categorical outcomes within the trial's statistical framework. The corresponding effect measure reported in the registry is an odds ratio rather than a hazard ratio.
Why does the full analysis set matter?
The registry states that the FAS included all randomized participants. An analysis anchored to randomization preserves the comparison created by random allocation. Restricting efficacy analysis only to participants who remained on treatment could introduce differences related to treatment discontinuation or post-randomization behavior that randomization itself did not balance.
What does censoring mean for these endpoints?
For a time-to-event endpoint, a participant who has not experienced the specified event by the end of observed follow-up does not simply count as an event-free participant forever. Instead, the participant contributes information up to the censoring time. Kaplan-Meier and related survival methods are designed to incorporate that partial follow-up.
11. Understanding the Primary Result More Carefully
Relative effect
The primary PFS estimate was an HR of 1.21. This is a relative time-to-event measure, not an absolute difference in the percentage of participants who experienced progression or death.
Uncertainty
The 95% CI of 0.928–1.573 gives a substantially broader range than the point estimate alone. Reporting the interval prevents the HR from being interpreted as a precise fixed quantity.
Statistical test
The reported P-value was 0.9199 from the log-rank analysis. It describes the statistical comparison under the specified hypothesis and does not measure the size of the observed HR.
Analysis population
The registry states that the FAS included all randomized participants. This is the population used for the reported primary and secondary efficacy analyses.
The most statistically informative way to read the primary result is therefore as a package: the endpoint definition establishes what event was being measured; the Kaplan-Meier/log-rank framework accounts for event timing and censoring; the hazard ratio summarizes the relative treatment comparison; the confidence interval communicates uncertainty; and the P-value describes the formal statistical test.
12. Confidence Intervals Across the Reported Analyses
| Endpoint | Estimate | Lower limit | Upper limit | Null value included? |
|---|---|---|---|---|
| PFS | 1.21 | 0.928 | 1.573 | Yes |
| OS | 1.31 | 0.927 | 1.849 | Yes |
| Time to locoregional failure | 1.25 | 0.930 | 1.694 | Yes |
| ORR | 0.947 | 0.663 | 1.352 | Yes |
| Time to distant metastatic failure | 1.21 | 0.909 | 1.624 | Yes |
For both hazard ratios and odds ratios, the null value is 1. A confidence interval containing 1 indicates that the interval includes equality between the groups on the reported relative-effect scale. This does not mean that the groups are proven identical; it means that the interval does not exclude the null value at the stated confidence level.
13. Effect Measures: Hazard Ratio vs Odds Ratio
| Feature | Hazard ratio | Odds ratio |
|---|---|---|
| Used in this trial for | PFS, OS, time to locoregional failure, time to distant metastatic failure | Objective response rate |
| Outcome structure | Time-to-event | Binary |
| Null value | 1 | 1 |
| Time information retained? | Yes | No |
| Example from this trial | PFS HR 1.21 | ORR OR 0.947 |
These effect measures should not be placed on the same scale conceptually. A hazard ratio incorporates event timing and censoring through survival analysis, whereas an odds ratio compares the odds of a binary outcome under the specified analysis. The numerical value of one cannot be interpreted identically across all statistical measures even though the null value happens to be 1 for both.
14. Multiplicity and the Superiority Framework
The ClinicalTrials.gov record identifies superiority as the hypothesis type for the primary and secondary statistical analyses. The primary endpoint is PFS, while OS, time to locoregional failure, ORR, and time to distant metastatic failure are secondary endpoints.
| Endpoint role | Endpoint | Hypothesis type | Method |
|---|---|---|---|
| Primary | PFS | Superiority | Log-rank |
| Secondary | OS | Superiority | Log-rank |
| Secondary | Time to locoregional failure | Superiority | Log-rank |
| Secondary | ORR | Superiority | Cochran-Mantel-Haenszel |
| Secondary | Time to distant metastatic failure | Superiority | Log-rank |
Multiple endpoints create a broader inferential context than a single hypothesis test. The ClinicalTrials.gov record identifies the endpoint roles and methods but do not provide an alpha-allocation or multiplicity-adjustment strategy. Consequently, this page does not infer a familywise error-control procedure from the reported P-values.
15. Blinding and Randomization as Statistical Design Features
The trial is registered as randomized and quadruple-masked. Randomization is fundamental because treatment assignment is determined independently of participants' eventual outcomes, providing the basis for an unbiased comparison in expectation. Quadruple masking is likewise a design feature intended to reduce knowledge of treatment assignment among relevant trial participants or personnel.
These features do not guarantee identical observed outcomes or eliminate every source of uncertainty. Rather, they establish the framework in which differences between randomized groups can be analyzed without treating post-randomization differences as though they were created by the investigators.
The key statistical benefit of randomization is protection against systematic baseline confounding in the treatment comparison. The actual observed groups can still differ by chance, and the ClinicalTrials.gov record does not provide a baseline-characteristics table.
16. What the Registry Does Not Provide in the Supplied Data
The ClinicalTrials.gov record contains the primary and secondary formal statistical analyses but do not provide several types of detail that would be needed for a more extensive reconstruction of the trial's statistical history.
- Median PFS: not reported in the ClinicalTrials.gov record.
- Median OS: not reported in the ClinicalTrials.gov record.
- Kaplan-Meier event curves: no underlying event/censoring data are reported.
- Subgroup analyses: no subgroup estimates or confidence intervals are reported.
- Baseline characteristics: no baseline demographic or disease-characteristic table is reported.
- Detailed multiplicity procedure: no alpha allocation or adjustment procedure is reported.
- Interim-analysis procedure: no interim boundary or alpha-spending method is reported.
- Missing-data/imputation strategy: no formal imputation procedure is reported.
- Bayesian methods: no Bayesian analysis is identified in the ClinicalTrials.gov record.
- Stratification factors: the ClinicalTrials.gov record does not identify trial stratification variables.
17. Limitations
- Registry-level detail: this analysis is constrained to the ClinicalTrials.gov record. It does not reconstruct unprovided protocol, SAP, or publication-level details.
- No median survival estimates: the ClinicalTrials.gov record does not report median PFS or median OS, so those measures are not presented.
- No absolute event rates: the registry-reported efficacy analyses provide relative effect estimates but do not provide the underlying event percentages or Kaplan-Meier estimates needed for an absolute-risk summary.
- No subgroup analysis: subgroup treatment effects are not reported and therefore cannot be inferred from the overall estimates.
- Hazard-ratio interpretation: an HR is a model-based relative time-to-event measure and should not be interpreted as a simple probability ratio or absolute risk difference.
- Censoring: the time-to-event endpoints explicitly include censored observations, so interpretation depends on how follow-up and censoring contribute to the analysis.
- Multiple endpoints: the registry identifies primary and secondary endpoints but does not supply the detailed multiplicity strategy in the ClinicalTrials.gov record.
- Safety denominator: serious adverse events are reported using affected/at-risk counts, and the ClinicalTrials.gov record does not provide a formal comparative test for this safety measure.
- Termination status: the registry identifies the study as terminated, but the ClinicalTrials.gov record does not provide a reason for termination. No reason is inferred here.
18. Why This Trial Matters Statistically
JAVELIN Head and Neck 100 is a useful teaching example because its registry results place several core clinical-trial concepts side by side. The primary endpoint is a time-to-event outcome analyzed with Kaplan-Meier and log-rank methods, while a secondary binary endpoint uses the Cochran-Mantel-Haenszel framework and an odds ratio. The same randomized comparison therefore requires different statistical tools depending on the structure of the endpoint.
| Concept | How it appears in this trial |
|---|---|
| Randomization | The study is registered as randomized. |
| Blinding | The study is registered as quadruple-masked. |
| Kaplan-Meier estimation | Used for the primary PFS analysis. |
| Log-rank test | Used for PFS, OS, time to locoregional failure, and time to distant metastatic failure. |
| Hazard ratio | Used as the effect measure for four time-to-event analyses. |
| Confidence interval | Two-sided 95% CIs are reported for all five statistical analyses. |
| Odds ratio | Used for the binary ORR endpoint. |
| Cochran-Mantel-Haenszel test | Used for ORR. |
| Full analysis set | All reported efficacy analyses used the FAS, defined as all randomized participants. |
| Superiority testing | The analyses posted on ClinicalTrials.gov identify superiority as the hypothesis type. |
The particularly important lesson is that a clinical-trial result is not just a P-value. A statistically literate reading starts with the estimand-like question embodied in the endpoint, identifies the analysis population, examines the effect measure, reads the confidence interval, and then considers what the hypothesis test contributes to that interpretation.
19. A Structured Reading of the Five Reported Analyses
| Step | Question | JAVELIN Head and Neck 100 |
|---|---|---|
| 1 | What was measured? | PFS, OS, time to locoregional failure, ORR, and time to distant metastatic failure. |
| 2 | Who was analyzed? | Full analysis set including all randomized participants. |
| 3 | What statistical family was used? | Survival analysis for four time-to-event endpoints; categorical-data analysis for ORR. |
| 4 | What was the effect measure? | Hazard ratio for time-to-event endpoints; odds ratio for ORR. |
| 5 | What is the estimate? | HR 1.21 for PFS; HR 1.31 for OS; HR 1.25 for time to locoregional failure; OR 0.947 for ORR; HR 1.21 for time to distant metastatic failure. |
| 6 | How precise is it? | Each reported 95% CI includes 1. |
| 7 | What is the formal test result? | P-values range from 0.6229 to 0.9372 across the five reported analyses. |
This framework avoids a common mistake in trial interpretation: starting with the P-value and working backward. The endpoint and analysis method come first. The effect estimate and confidence interval then describe the observed treatment comparison and its uncertainty, while the P-value supplies the formal test result.
20. Clinical Interpretation vs Statistical Interpretation
Statistical interpretation
The registry analyses report relative effect estimates for five efficacy endpoints. The primary PFS HR is 1.21 with a two-sided 95% CI of 0.928–1.573 and P = 0.9199. The four secondary analyses likewise report confidence intervals that include the null value of 1.
Clinical interpretation
The registry data alone do not provide median survival, absolute survival estimates, response percentages, subgroup results, or other clinical-effect summaries needed for a broader clinical interpretation. Those quantities are therefore not inferred here.
This distinction is important. Statistical analysis can precisely describe what the registry-reported estimates say without claiming more than the data support. In particular, a hazard ratio should not be converted into an absolute benefit, and the absence of an interval excluding 1 should not be transformed into a claim that two treatments are identical.
21. Statistical Concepts in This Trial
Learn more about the methods used in this trial:
22. Related Statistical Calculators
Use these related tools to explore the statistical quantities that appear in the reported analyses:
23. Sources
- ClinicalTrials.gov: JAVELIN Head and Neck 100, NCT02952586.
- Linked publication: PubMed record for PMID 33794205.
Continue through Clinical Biostats
Explore the statistical concepts behind randomized clinical trials, time-to-event endpoints, categorical outcomes, and treatment-effect measures.
24. Record Summary
JAVELIN Head and Neck 100 provides a compact example of how different clinical-trial endpoints require different statistical approaches. The primary endpoint, investigator-assessed PFS, is a time-to-event outcome analyzed with Kaplan-Meier and log-rank methods and summarized with a hazard ratio. OS, time to locoregional failure, and time to distant metastatic failure use the same broad survival-analysis framework. ORR, by contrast, is a binary endpoint analyzed using the Cochran-Mantel-Haenszel test and summarized by an odds ratio.
The ClinicalTrials.gov record reports a PFS HR of 1.21 (95% CI 0.928–1.573; P = 0.9199), an OS HR of 1.31 (95% CI 0.927–1.849; P = 0.9372), a time-to-locoregional-failure HR of 1.25 (95% CI 0.930–1.694; P = 0.9316), an ORR OR of 0.947 (95% CI 0.663–1.352; P = 0.6229), and a time-to-distant-metastatic-failure HR of 1.21 (95% CI 0.909–1.624; P = 0.9061).
The most useful statistical reading is not any single number in isolation. It is the combination of endpoint definition, randomized analysis population, appropriate statistical method, effect estimate, confidence interval, and hypothesis-test result. The ClinicalTrials.gov record supports that structured interpretation without requiring unsupported assumptions about median survival, subgroup effects, multiplicity, or other unreported design details.